MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag— 510(k) K193191
Substantially EquivalentWeinmann Emergency Medical Technology GmbH + Co. KG
FDA 510(k) clearance K193191 for MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag, Substantially Equivalent on 2020-11-20. Applicant: Weinmann Emergency Medical Technology GmbH + Co. KG.
Clearance details
- Applicant
- Weinmann Emergency Medical Technology GmbH + Co. KG
- Product code
- Code BTL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Adverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.